Apparatus for the collection and cooling of blood



` Aug. 5, 1958 M. M. srRUMlA 2,845,929

APPARATUS Foa THE COLLECTION AND cooLING oF BLoon Filed April 30. 1953 3 Sheets-Sheet 1 I' lo "Ill N I H Il l II mvENToR MAX M. 5 TRuM/A ArroRNEY Aug. 5, 1958 M. M. sTRUMlA APPARATUS FOR THE COLLECTION AND COOLING OF BLOOD Filed April 50, 1953 5 Sheets-SheetI 2 uw n N bmm o o Aug' 5, 1958 M. M. sTRUMlA 2,845,929

APPARATUS FOR THE COLLECTION ANO COOLING OF BLOOD Filed April so, 195s 3 Sheets-Sheet 3 INVENTOR MAX M STRUM/A l BY /f Unittd APPARATUS FoR THE COLLECTION AND cooLlNG or BLOOD Max M. Strumia, Bryn Mawr, Pa., assignor to the United States of America as represented by the Administrator of the Federal Security Agency Application April 30, 1953, Serial No. 352,313

Claims. (Cl. 12S-276) (Granted under Title 35, U. S. Code (1952), sec. 266) the collection of blood.

For a long period of time considerable variations have been noted between units of blood collected in the same preservative and stored under identical conditions. While differences exist between the bloods of apparently normal donors, the differences in results of studies on preservation are too great to be explained solely on this basis. lt has, therefore, been determined that the manner of collection and cooling of the blood, and of 'mixing the blood with the anticoagulant solution is responsible-for at least a portion of the diiculties noted.

Accordingly, an object of this invention is to provide a method and apparatus which permits the collection of'blood, cooling of the blood, and mixing of the blood with anticoagulant solution under reproducible conditions.

Another object of the invention is to provide an apparatus for drawing blood at a controlled uniform rate.

Another object of the invention is to provide apparatus `for vdrawing blood under a constant, controlled low vacuum.

yAnother object of the invention is to provide means for cooling the blood rapidly as it leaves the vein before mixing with the anticoagulant solution.

Another object of the invention is to provide means for vmixing the blood with anticoagulant solution by gentle rocking at a uniform and reproducible rate.

Another object of the invention is to 'provide means `for maintaining the blood cold during collection and Another object of the invention is to provide means for continuously measuring the exact amount of blood drawn.

These land related objects and advantages will be 'made'clear from the following description of the invention taken Kwith the accompanying drawings in which:

Fig. l is aside elevation view of the blood-collecting apparatus of this invention partially diagrammatic and partially in section for the purpose of clarity of illustration.

tFig. 2 is an end view of a container for a collapsible blood-collecting bag comprising a part of the apparatus shown in Fig. l.

Fig. -3 is a'sectional view taken on the line 3 3 of Fig. 2 andshowing the means for sealing the collapsible bag in the container and for supporting the latter.

Fig. VV4 is a sectional view taken on the line4 4 of Fig. 3.

Fig. 5 `is a `fragmentary sectional detail view taken "on the line 5 5 of Fig. 2.

Fig. 6 is a bottom plan View of a split ring closure Ymember `for the container shown in Fig. 2.

Fig 7'is a sectional view of the split-ring member taken on the line 7 7 of Fig. "6.

tes atent `of illustration are omitted from Fig. 1.

`l1`ori2ontal axis through the pivot pins,

Fig. 8 is a sectional view of the split-ring member taken on the line 8 8 of Fig. 6.

Fig. 9 is a plan View showing the top cover plate of the container of Fig. 2.

Fig. 10 is a view similar to Fig. 9 showing a diaphragm sealing member for the container of Fig. 2.

Fig. 11 is a View similar to Fig. 9 showing a gasket member.

Fig. 12 is a View similar to Fig. 9 lshowing an intermediate closure plate.

Fig. 13 is a view similar to Fig. 9 showing Aanother gasket member. v

Fig. 14 is a view similar to Fig. 9 showingabottom cover plate.

Fig. l5 is a view similar t-o Fig. 9 showing another gasket member.

The method for collecting blood, according to this invention, comprises withdrawing the blood from the vein of a donor at a constant controlled rate, cooling the blood continuously as it is withdrawn, mixing the cooled blood with anticoagulant solution by agitation at a constant rate, maintaining a constant low temperature during the mixing, continuously measuring the exact amount of blood collected, and stopping the withdrawal of blood when the desiredamount has 'been withdrawn.

Referring now to the drawings, in detail, and particularly to Fig. 1 thereof, the apparatus for accomplishing the purposes of this invention is shown ras comprising "a `tank 10 for containing a cooling liquid, which may be water, brine, or other suitable coolant, and which is provided with a circulating line 11 having a circulatingA pump 12. The coo-ling liquid may be cooled With ice or by circulating coolant through suitable heat-exchange pipes 13 which are connected to a refrigerating system, not shown. A temperature gauge 14 is -provided to indicate the temperature of the liquid in the tank. It will be understood that suitable thermostatic control means may be provided to maintaina constant temperature of the cooling liquid in the tank 10.

The cooling tank 10 is provided with a well portion 15 which is perforated as at 16 to permit the circulation of cooling liquid, and which accommodates a lightfmetal spool 17 having tins 18 around which is coiled a po-rtion of the plastic tubing 19 by which blood is collected. The spool 17 is provided with a handle 20 by which it may be Withdrawn from the well 15 when desired. The length of the tubing 19 may vary depending upon the degree to which the withdrawn blood is to be cooled. For example, with a length of tubing of-260 centimeters, the bulk of which is immersed in the cooling liquid of the tank, and with water in the tank maintained at a temperature around 1 C., the blood Withdrawn from the donor at the normal temperature of 37 C. is delivered to the collecting bag at a temperature of about 8 C. Lower temperatures can be obtained by a longerleng'th tubing and a larger number of coils, or by use-of a cooling liquid maintained at a lower temperature. The tubing 19 is provided at one end with a needle-21 for the purpose of entering the vein of thedonor and with a similar needle 21a at the other end for the purpose of entering the cap of the plastic blood-collecting bag.

A container 22, which may be cylindrical in shape and of transparent material such as Lucite, is mounted on the top of tank lil by means of supporting brackets23 and arms Z4. The supporting means, including brackets 23 and arms 24, are shown in Fig. 3, but for simplicity `As shown in Fig. 3, the arms 24 are rigidly fixed to the container 22 `as at 25A and are pivotably xed at the other ends'thereof to the brackets 23 by means of pins 26 whereby the container 22 and its contents may be rocked abouta VA rocking mechanism provided for this purpose comprises motor 27, gearing 28, crank arm 29, and driving arm 30 connected to a sidewall of the container 22 at 31. By means of a `suitabie reduction gearing and crank arm, the container 22 may be rocked, for example, through an angle of about 15 during the blood collection, with the rate of rocking being approximately twelve full excursions per minute.

The container 22 is designed to accommodate a plastic collapsible blood collecting bag 32. As shown in Fi-gures 2, 3, and 4 this bag has an elongated oval shaped neck portion 33 having extending ilange-like members 34 on each side of the widest dimension and having a cap or top 35. The bag 32 is held and sealed in the container 22 by means of a split-collar 36, a series of plates 37, 3S and 39, gaskets 40, 41, and 42, and by a thin iiexible rubber diaphragm member 43, the details of each being shown in Figures 6 to l5.

The plastic bag 32 may be assembled to the closure and sealing members and the assembly then attached to container 22. Thus, the neck portion 33 of the bag 32 is drawn through the central aperture 44 of bottom plate 39. This plate is provided with six studs 45, shown in Figures 2 and 3, over which the covering gaskets and plates are fitted, holes in these members registering with the studs. The split collar 36, Figures 6, '7, and S, rits tightly around the neck portion 33 of the 'bag 32 and grips the projecting flange members 34 between the two sections thereof. Projecting members 46 in split collar 36 register with holes 47 in the projecting harige members 34 and provide against slippage of the bag 32. A ringlike base portion 48 of the collar 36 rests on plate 39. Rubber gasket 4l also rests on this plate around the periphery of the base 48 of collar 36 and provides a seal between bottom plate 39 and the next or intermediate plate 38. Plate 3S has a central aperture i9 of smaller diameter than that of plate 39 and lits snugly around the split collar 36 above the base 418, enlarged portions 5i) of the aperture 49 accommodating flanges 51 of the collar 36. The top aperture 52 of the split collar 36 is of the same oval shape as the neck portion of the plastic bag immediately below the cap 35 thereof and fits snugly around the bag neck in this area.

As shown in Figure 4, intermediate plate 38 is secured to the bottom plate 39 by means of countersunk dat-headed screws 53, a seal being formed between these two plates lby rubber gasket 4l. Rubber gasket 46 is then placed on the plate 33, and the thin flexible rubber diaphragm 43 is stretched over the cap 35 of bag 32 with slit 54 of the diaphragm expanding suiciently to accommodate the cap and form a tight seal. Top cover plate 37 nts over the edges of the diaphragm and seals them to the rubber gasket 4), the whole assembly 'being drawn tight by thumb nuts 55 on studs 45. The bag 32 may then be Iplaced in container 22 with holes 56 in the bottom plate 39 registering with studs 57 set in circular ange S around the end of the containerlFig. 5). Rubber gasket 42 lits between the bottom plate and the surface of flange 53. The assembly is secured to the container 22 by tightening thumb nuts 59 on studs 57.

'It will be understood that a number of closure assemblies may be provided for a single container 22 so that the plastic bags and closure assemblies may be quickly removed and replaced. It will also be understood that the closure means shown are for purposes of illustration only and that many modications or such means are possible, as will appear to one skilled in the art, and are to be considered within the scope of this invention.

The container 22 is connected to the cooling tank 1i? by means of a flexible hose 6G the end 6l of which extends below the liquid level in the tank so that liquid may be drawn from the tank 1t! through the hose 69 into container k22 or may be drained from the container 22 into the tank depending upon the stage of operation.

4 A pinch valve 62 is provided in the hose so that the connection may be closed or opened as desired.

Also connected to the container 22 is a flexible hose -connection 63 to line 66 which is connected by means of valve 65 to the top of a graduated transparent measuring vessel 66. A valve 67 in line 64 opens to the atmosphere. The graduated measuring vessel 66 is provided with a drain pipe 68 having a valve 69 and emptying back into the tank or to waste.

A vacuum lline 7i) is connected to the top of the graduated vessel and to a vacuum pump not shown. A vacuum gage 71 is connected in line 70 by means of a by-pass line. Vacuum line 75 also contains a valve 72 whereby the vacuum may be closed oi, and a valve 73 which vents to the atmosphere.

'ln operation of the apparatus, after a plastic bag has been suitably inserted into the container 22 and the connections tightened, a vacuum of, for example, live to fteen inches of mercury is created in the graduated vessel 66 by starting the vacuum pump, opening valve 72 and closing valves 65, 69 and 73. Then, with valve 67 closed and pinch-valve 62 open, opening of valve 65 causes water to be drawn from tank 19 thro-ugh conduit 61 into container 22. By releasing the water back into the tank and re'lling several times adequate cooling of both container 22 and its contents can be achieved.

lt will be understood that the plastic bag 32 as it is placed in container 22 already contains anticoagulant `solution and is completely sealed. The bag contains no air, and since its total capacity when completely lled is more than 600 milliliters, the bag before collection of the blood, appears substantially empty.

In preparation for blood collection, after adequate cooling and filling of the container 22 with cooling liquid, the valve 65 is closed and the level of the liquid in the measuring vessel is regulated to zero by opening drain valve 69 and vent 73. These valves are then closed and a constant vacuum is maintained in the measuring vessel 66 by regulating valve 72.

In order to avoid air entering the plastic blood collecting bag, and causing, later on, frothing, the needle 21a may be introduced into the top of the bag and the plastic tube 19 allowed to become completely lled with the anticoagulant solution. The needle 21 is then introduced into the donors vein vas shown in Fig. l, and valve 65 is opened permitting liquid from container 22 to be drawn `by the press-ure diierential between container 22 and vessel 66 into measuring vessel 66. Blood is Withdrawn into the plastic bag 32 at the same rate that liquid is displaced from container 22.

Alternatively, to avoid air in the system, needle 21 could be inserted in the patients vein and blood permitted to ll the plastic tubing 19 by gravity before needle 21a is introduced into the rubber top of the plastic bag. Valve 65 would be opened immediately to permit the vacuum to take over.

By properly manipulating valve 65, van even, adequate ow of blood can be maintained. An immediate evaluation of the rate of ilow can be rnade by observing the dripping of liquid into the measuring vessel 66 and the rising level of liquid in this vessel.

During the collection of blood the coiled plastic tube is kept immersed in the circulating cooling tank so that blood as delivered to the plastic bag may be cooled to 10 C. or less.

The rocking mechanism may be started simultaneously with the beginning of the blood collection so that the blood as delivered to the plastic bag is adequately and uniformly mixed with the anticoagulant solution.

When the proper amount of blood has been collected, as evidenced by the liquid level in measuring vessel 66, valve 65 is closed, the needle 21 is removed from the patients arm and needle 21a is removed from the top of `bag 32 which is automatically sealed. The container 22 is then drained by opening valve 62. The plastic blood-filled bag 32 is then removed and for convenience and continued storage and cooling may be immersed in the cooling tank 10.

The method and 'apparatus of this invention overcomes one of the major diiculties heretofore encountered with the use of plastic bags, namely, the difficulty in ycollecting blood at a regular rate. Plastic bags, particularly where cooled prior to collection of blood or maintained cold during collection have a tendency to become stiff so that the full amount of -blood cannot be obtained. This trouble is not encountered where a vac-uum is used as in the present method and apparatus.

While the invention has been shown and described with relation to plastic bags and in particular one of the type known as an Abbott Blood Collecting Container, the principle can be applied to any type of collapsible container. For example, vcontainers which have a fitted-in plastic tube, such as the Fenwal bags, may be used by simple modifications of the rubber diaphragm closure means. Likewise, the device may be adapted to accommodate collapsible containers of other sizes and shapes, and provided with various types of tops.

The method and apparatus described permits the collection of blood into cooled containers at a regular rate, with proper mixing and with accurate measurement of the amount collected. Thus, it is possible to rigidly standardize the collection of blood so that variable factors are eliminated and uniform quantities may be obtained for testing, preserving in a blood-bank or for other uses. The apparatus is suticiently simple in operation that unskilled personnel may be trained in its use in a short time, and in addition its use may extend for a substantial period of time the expected survival of red blood cells.

It will be appreciated from a reading of the foregoing specilication that the invention herein described is susceptible of various changes and modifications Without departing from the spirit and scope thereof.

What is claimed is:

1. Apparatus for the collection of blood comprising a tank for cooling liquid, a container adjacent said tank, valved connecting means between said tank and container, a collapsible bag in said container, means for sealing said container around the neck of said bag, a length of tubing partially disposed in said tank and having connecting means at one end for connecting said tubing with said collapsible bag and connecting means at the other end for insertion in the vein of a blood donor, a closed measuring vessel connected to said con? tainer, and means for exerting a vacuum on said measuring vessel whereby liquid from said container is drawn through said tubing into said measuring vessel.

2. Apparatus for collecting blood from the vein of a patient, comprising a needle adapted to be inserted into said vein, a flexible bag of impervious material collapsed to be free of air lcontent and adapted to serve as a reservoir for blood, a tube leading from the needle to the interior of the bag constituting a conduit for blood from the needle to the bag, means for chilling the tube to temperatures below about 10 degrees centigrade whereby the blood is chilled on its way to the bag, means for applying constant, controlled suction to the exterior surface of the bag to expand the bag whereby reduced pressure formed within the bag withdraws blood from the vein of the patient through the needle to the bag at a controlled uniform speed, said bag adapted to contain blood anticoagulant, and means for continuously applying gentle rocking to the bag whereby the blood in the bag is mixed with the anti-coagulant.

3. Apparatus for collecting blood from the vein of a patient, comprising a needle adapted to be inserted into -said vein, a exible bag of impervious material collapsed to be free of air content and adapted to serve as a res`- ervoir for blood, a tube leading from the needle to the interior ofthe bag constituting a conduit for blood from the needle to the bag, means for chilling the tube to temperatures below about l0 degrees centigrade whereby the blood is chilled on its way to the bag, means for applying constant, controlled suction to the exterior surface of the bag to expand the bag whereby reduced pressure formed within the bag withdraws blood from the vein of the patient through the needle to the bag at a controlled uniform speed, the means for applying constant, controlled suction to the bag comprising a iluid tight housing surrounding the bag, a source of suction, a conduit leading from the housing to the source of suction and adapted to contain liquid filling the housing and lconduit whereby the liquid can be withdrawn by the suction from the housing to expand the bag.

4. Apparatus for collecting blood from the vein of a patient, comprising a needle adapted to be inserted into said vein, a exible bag of impervious material collapsed to be free of air content and adapted to serve as a reservoir for blood, a tube leading from the needle to the interior of the bag constituting a conduit for blood from the needle to the bag, means for chilling the tube to temperatures below about 10 degrees centigrade whereby the blood is chilled on its way to the bag, means for applying constant, controlled suction to the exterior surface of the bag to expand the bag whereby reduced pressure formed within the bag withdraws blood from the vein of the patient through the needle to the bag at a controlled uniform speed, the means for applying constant, controlled suction to the bag comprising a fluid tight housing surrounding the bag, a source of suction, a measuring vessel, a conduit leading from the housing into the measuring vessel, and adapted to contain liquid filling the housing and conduit whereby the liquid can be withdrawn by the suction from the housing to drop into the measuring vessel thereby expanding the bag, the volume and rate of ilow of liquid drawn into the measuring vessel being a measure of the volume and rate of flow of blood drawn into the bag.

5. Apparatus for collecting blood from the vein of a patient, comprising a needle adapted to be inserted into said vein, a exible bag of impervious material collapsed to be free of air content and adapted to serve as a reservoir for blood, a tube leading from the needle to the interior of the bag constituting a conduit for blood from the needle to the bag, means for applying constant, controlled suction to the exterior surface of the bag to expand the bag whereby reduced pressure within the bag withdraws blood from the vein of the patient through the needle to the bag at a controlled uniform speed, and means for continuously chilling the tube and bag to temperatures below approximately 10 degrees centigrade whereby the blood as withdrawn from the vein is chilled to and maintained at a temperature below about 10 degrees centigrade.

References Cited in the le of this patent UNITED STATES PATENTS 1,939,611 Purvis Dec. 12, 1933 1,963,097 Poe June 19, 1934 2,063,430 Graser Dec. 8, 1936 2,074,223 Horiuchi Mar. 16, 1937 2,328,569 McGaw Sept. 7, 1943 2,597,715 Erikson May 20, 1952 2,678,159 Ellis May 11, 1954 2,702,034 Walter Feb. 15, 1955 FOREIGN PATENTS 663,760 France Apr. 15, 1929 

